Delivery device with a protective sleeve

• US 5,238,687 A
• Filed: 09/02/1992
• Issued: 08/24/1993
• Est. Priority Date: 07/11/1990
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Magruder, Judy A., Eckenhoff, James B., Peery, John R.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): BROUILLETTE, D GABRIELLE
• Application Number:
  US07/939,186
• Time in Patent Office: 356 Days
• Field of Search: 424/473
• US Class Current: 424/473
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

Abstract

This invention relates to an active agent delivery device. More particularly, the invention relates to a delivery device that includes a sleeve to protect the delivery device from transient mechanical forces. The delivery device of the invention is robust and resistant to transient mechanical forces. The invention provides a fluid-imbibing delivery device comprising a housing enclosing an internal compartment, said housing having a first wall section that substantially restricts the passage of fluid into the delivery device, i.e. is substantially fluid-impermeable, and that contains a beneficial agent; a second wall section that permits the passage of fluid into the delivery device, i.e. is fluid-permeable, and that contains at least one expandable driving member; and exit means; with a protective sleeve means extending from the first wall section of the housing to cover and protect the second wall section of the housing and the junction of the first and second sections. The protective sleeve is preferably configured to provide substantially no resistance to flow of fluid-vapor through the fluid-permeable second wall section.

Claims

1. A fluid-imbibing dispenser for delivering a beneficial agent to an animal, the dispenser comprising:

(a) a first wall section comprising a wall that surrounds an internal compartment and an open end;

(b) a second wall section comprising a wall that surrounds an internal compartment and an open end, the wall comprising a composition permeable to the passage of fluid, wherein the open end of the first wall section and the open end of the second wall section are in mated contact;

(c) a rigid sleeve extending from the first wall section to cover the junction of the first wall section and the second wall section and to at least partially cover the sides of the second wall section, the inside diameter of the sleeve being greater than the outside diameter of the second wall section, and the sleeve being able to resist transient mechanical forces of at least about 2 kilograms force;

(d) a beneficial agent in the compartment comprising the first wall section;

(e) at least one expandable driving member in the compartment comprising the second wall section for pushing the beneficial agent from the compartment;

(f) a partition layer substantially impermeable to fluid between the beneficial agent and the expandable member; and

(f) exit means for delivering the beneficial agent to the animal.

2. A dispenser according to claim 1 wherein the exit means comprises an exit passageway and means for closing the exit passageway.

3. A dispenser according to claim 2 wherein the means for closing the exit passageway is a break-off tab.

4. A dispenser according to claim 2 wherein the means for closing the exit passageway is a material which get discharged, leaches or erodes.

5. A dispenser according to claim 1 wherein the sleeve resists transient mechanical forces of about 6 kilograms force.

6. A dispenser according to claim 1 wherein the sleeve has a minimum tensile strength of about 9000 psi.

7. A dispenser according to claim 1 wherein the sleeve completely covers the sides of the second wall section and extends to or below the rear end of the second wall section.

8. A dispenser according to claim 1 wherein the sleeve further comprises a plurality of ridges on its inner circumference.

9. A dispenser according to claim 1 wherein the sleeve further comprises a plurality of fluid or fluid vapor passage means.

10. A dispenser according to claim 1 which comprises 2 or 3 driving members.

11. A dispenser according to claim 10 wherein the driving members comprise an osmopolymer together with an osmagent.

12. A dispenser according to claim 1 wherein the open end of the first wall section is enlarged and the open end of the second wall section is placed in the open enlarged end of the first wall section.

13. A dispenser according to claim 1 wherein the animal is a swine or a bovine.

14. A dispenser according to claim 1 wherein the beneficial agent is a hormone.

15. A dispenser according to claim 1 wherein the first wall section is impermeable to the passage of fluid, and the beneficial agent is a somatotropin, a somatotropin derivative or a somatotropin analogue.

16. A dispenser according to claim 1 wherein the animal is a hog and the beneficial agent is porcine somatotropin.

17. A dispenser according to claim 1 which is an implant.

18. A dispenser according to claim 16 wherein the dispenser is an implant.

19. A dispenser according to claim 18 wherein there are two expandable driving members;

the exit means comprises an exit passageway and means for closing the exit passageway;

the means for closing the exit passageway is a material which gets discharged, leaches or erodes; and

the sleeve resists transient mechanical forces of from about 2 kilograms force to about 6 kilograms force.

20. A dispenser according to claim 19 wherein the sleeve completely covers the sides of the second wall section and extends to or below the rear end of the second wall section.

21. A dispenser according to claim 20 wherein the sleeve further comprises a plurality of ridges on its inner circumference.

22. A method for delivering a beneficial agent to an animal, wherein the method comprises:

(1) admitting into the animal a dispenser comprising;

(a) a first wall section comprising a wall that surrounds an internal compartment and an open end;

(b) a second wall section comprising a wall that surrounds an internal compartment and an open end, the wall comprising a composition permeable to the passage of fluid, wherein the open end of the first wall section and the open end of the second wall section are in mated contact;

(c) a rigid sleeve extending from the first wall section to cover the junction of the first wall section and the second wall section and to at least partially cover the sides of the second wall section, the inside diameter of the sleeve being greater than the outside diameter of the second wall section, and the sleeve being able to resist transient mechanical forces of at least about 2 kilograms force;

(d) a beneficial agent in the compartment comprising the first wall section;

(e) at least one expandable driving member in the compartment comprising the second wall section for pushing the beneficial agent from the compartment; and

(f) exit means for delivering the beneficial agent to the animal;

(2) allowing fluid to be imbibed through the permeable second wall section of the dispenser for causing the expandable driving member or members to increase in volume; and

(3) delivering the beneficial agent to the animal by the driving member of members increasing in volume and occupying space in the compartment comprising the first wall section, thereby pushing the beneficial agent through the exit means to the animal.

23. A method according to claim 22 wherein the sleeve resists transient mechanical forces of about 6 kilograms force.

24. A method according to claim 22 wherein the sleeve has a minimum tensile strength of about 9000 psi.

25. A method according to claim 22 wherein the sleeve completely covers the sides of the second wall section and extends to or below the rear end of the second wall section.

26. A method according to claim 22 wherein the sleeve further comprises a plurality of ridges on its inner circumference.

27. A method according to claim 22 wherein the sleeve further comprises a plurality of fluid or fluid vapor passage means.